CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 253 enrolled
Drug / intervention
rivaroxaban +1 moredrug
Likely dose
rivaroxaban 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01729871
NCT01729871Phase 3Completed
CompareCT.gov

A Randomized, Open-label, Active-controlled Multi-center Study to Assess Safety of Uninterrupted Rivaroxaban vs. Usual Care in Subjects Undergoing Catheter Ablation Therapy for Atrial Fibrillation

Janssen Scientific Affairs, LLC·interventional·Posted Nov 20, 2012·Updated Mar 6, 2017

In Brief

A Phase 3 clinical trial evaluating rivaroxaban and uninterrupted vitamin K antagonist (VKA) for Atrial Fibrillation. Completed, enrolled 253 participants across 44 sites in 5 countries.

Detailed Summary

The purpose of this exploratory study is to evaluate the safety of rivaroxaban and uninterrupted vitamin K antagonist (VKA) in adult participants with non-valvular atrial fibrillation (NVAF) who undergo catheter ablation as measured by post-procedure major bleeding events.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesBelgium, France, Germany, United Kingdom, United States
CollaboratorsBayer

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 20, 2012
Enrollment StartFeb 1, 2013
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.6 years ago

Interventions

rivaroxabandrug

rivaroxaban 20 mg orally, once-daily, administered preferably with the evening meal

uninterrupted vitamin K antagonist (VKA)drug

dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0